Transform Industries Through Cutting-Edge Additive Manufacturing!
Our client is at the forefront of the additive manufacturing revolution, pushing the boundaries of what's possible. They’re reshaping production across healthcare, aerospace, automotive, and beyond – and seeking a visionary Development Quality Engineering Manager to join the team and drive excellence in this rapidly evolving field.
The Challenge:
As Development Quality Engineering Manager, you will lead a team of quality engineers and technicians to support the development and manufacturing of our proprietary products and customer-designed products! Leveraging your expertise in quality engineering, risk management, project management, and Lean Six Sigma, you will play a crucial role in ensuring the highest levels of customer satisfaction through rigorous quality standards and innovative practices.
KEY RESPONSIBILITIES
Leadership and Team Management:
- Select, develop and evaluate personnel for proper allocation of development quality engineering tasks.
- Foster a collaborative and high-performance culture within the quality team.
- Set performance goals and conduct regular performance evaluations for team members.
Design Controls & Quality Assurance:
- Oversee the implementation and maintenance of design control processes to ensure compliance with regulatory standards (e.g., FDA, ISO 13485, AS9100).
- Collaborate closely with product development, application innovation, and manufacturing teams to integrate quality into every stage of the design and development processes.
- Participate in customer project meetings and lead efforts to translate and understand part, project, and validation/certification requirements.
- Supports the conceptualization of new methodologies, materials, machines, processes or products.
Statistical Analysis & Risk Management:
- Apply statistical methods and tools to analyze data, identify trends, and make data-driven decisions to improve product quality.
- Lead risk management activities, including Failure Mode and Effects Analysis (FMEA) and risk assessments.
- Develop and monitor key quality metrics and report on the effectiveness of development quality activities.
- Investigate complex product issues, identify root causes, and manage the implementation of corrective actions.
Design for X (DfX) & Continuous Improvement:
- Promote and implement Design for X (DfX) methodologies to optimize product design for quality, manufacturability, reliability, and cost.
- Drive continuous improvement initiatives to enhance product quality, reduce defects, and improve efficiency.
- Lead comprehensive root cause analysis and corrective action processes to resolve quality issues promptly and effectively.
Regulatory Compliance & Audits:
- Ensure compliance with applicable regulatory and industry standards for medical devices, aerospace, and industrial products.
- Actively participate in internal and external audits, supporting regulatory inspections and ensuring audit readiness.
- Maintain awareness of regulatory changes and industry best practices.
Communication & Conflict Resolution:
- Lead the response to customer inquiries and escalations regarding product issues, ensuring timely and effective resolutions.
- Communicate effectively with cross-functional teams and senior management on quality-related matters, providing clear and actionable insights.
- Develop and deliver training programs to enhance quality awareness and skills across the organization.
QUALIFICATIONS
- Bachelor’s degree in engineering, science or technical field. Master’s degree in engineering or related field preferred.
- 6 years of progressive experience in quality engineering within highly regulated industries (medical devices, aerospace, automotive), with at least 2 years in a managerial role.
- Expert knowledge and practical experience in the use of Medical Device Design Control regulations (CFR 820.30, ISO 13485:2016 / EU MDR) and industry best practices.
- Proven expertise in implementing Medical Device Design and Development best practices, including Verification & Validation (V&V) processes in a streamlined and customer-focused manner.
- Demonstrated ability to lead a team: coaching, talent development, training, providing feedback, and collaborating.
- Self-motivated and capable of managing a diverse team, handling multiple assignments simultaneously, and achieving department goals.
- Strong project management, organizational, and problem-solving skills, with the ability to prioritize and coordinate resources to meet quality metrics. Ability to establish department goals and coordinate a wide variety of resources to meet quality metrics.
- Proficient computer skills, including experience with quality management software and tools.
- Excellent communication skills, both verbal and written, with the ability to effectively interact with a wide range of internal and external stakeholders.
- Certifications including but not limited to: Quality Engineer, Manager of Quality and Operational Excellence, Quality Auditor, and/or Six Sigma Black Belt from ASQ or other equivalent.
- This position requires the ability to review technical information from aerospace and defense customers.
What We Offer:
- Competitive compensation package: $120,000 - $140,000 base salary (commensurate with experience), plus an annual performance bonus plan based upon company performance
- Comprehensive benefits including premium health coverage, 401(k) matching, and ample paid time off
- Access to the latest in additive manufacturing technology
- Opportunities and support for career development
- Collaborative work environment that values innovation and out-of-the-box thinking
- Regular interaction with thought leaders in additive manufacturing and related fields
